Sojourn Inhalant

Name: Sojourn Inhalant

Indications & usage


Sojourn (sevoflurane, USP) is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.


Sojourn (sevoflurane, USP) should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.

Contraindications


Sevoflurane can cause malignant hyperthermia. It should not be used in patients with known sensitivity to sevoflurane or to other halogenated agents nor in patients with known or suspected susceptibility to malignant hyperthermia.

Overdosage


In the event of overdosage, or what may appear to be overdosage, the following action should be taken: discontinue administration of sevoflurane, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.

Dosage & administration

The concentration of sevoflurane being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using a vaporizer calibrated specifically for sevoflurane. The administration of general anesthesia must be individualized based on the patient's response.


Replacement of Desiccated CO2 Absorbents:

When a clinician suspects that the CO2 absorbent may be desiccated, it should be replaced. The exothermic reaction that occurs with sevoflurane and CO2 absorbents is increased when the CO2 absorbents become desiccated, such as after an extended period of dry gas flow through the CO2 absorbent canisters (see PRECAUTIONS).


Pre-anesthetic Medication:

No specific pre-medication is either indicated or contraindicated with sevoflurane. The decision as to whether or not to premedicate and the choice of pre-medication is left to the discretion of the anesthesiologist.


Induction:

Sevoflurane has a non-pungent odor and does not cause respiratory irritability; it is suitable for mask induction in pediatrics and adults.


Maintenance:

Surgical levels of anesthesia can usually be achieved with concentrations of 0.5 - 3 % sevoflurane with or without the concomitant use of nitrous oxide. Sevoflurane can be administered with any type of anesthesia circuit.




Age of Patient
    (Years)       

Sevoflurane
in Oxygen

Sevoflurane
in 65% N2O / 35% O2 
 0 - 1 months #
3.3% 
 
 1 - < 6 months
3.0% 
 
 6 months - < 3 years
2.8% 

 2.0%@
 3 - 12    
2.5%
 
 25
2.6%

 1.4%
 40
 2.1% 

 1.1%
 60    
 1.7% 

       0.9%     
 80
1.4%

  0.7%

  # Neonates are full-term gestational age. MAC in premature infants has not been determined.
@ In 1 - < 3 year old pediatric patients, 60% N2O / 40% O2 was used.


Manufactured by


Piramal Critical Care, Inc.

3950 Schelden Circle

Bethlehem, PA 18017


(888) 822-8431


*Baralyme® is a registered trademark of Allied Healthcare Products, Inc 
 

© 2015 Piramal Critical Care, Inc.

AWN-34525705

Bottle Label - 100 mL




SOJOURN 
sevoflurane liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66794-012
Route of Administration RESPIRATORY (INHALATION) DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVOFLURANE (SEVOFLURANE) SEVOFLURANE 1 mL  in 1 mL
Packaging
# Item Code Package Description
1 NDC:66794-012-25 250 mL in 1 BOTTLE, GLASS
2 NDC:66794-012-10 100 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077867 04/13/2010
Labeler - Piramal Critical Care Inc (805600439)
Establishment
Name Address ID/FEI Operations
Piramal Critical Care Inc 805600439 ANALYSIS(66794-012), API MANUFACTURE(66794-012), LABEL(66794-012), MANUFACTURE(66794-012), PACK(66794-012)
Revised: 10/2015   Piramal Critical Care Inc
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